Cleared Traditional

K992308 - OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138

K992308 is an FDA 510(k) clearance for OOCYTE RETRIEVAL NEEDLE SET, manufactured by Lifetek Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K992308 · Lifetek Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
66d
Days
Class 2
Risk

K992308 is an FDA 510(k) clearance for the OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Lifetek Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on September 13, 1999 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifetek Medical, Inc. devices

FDA 510(k) Submission Details - K992308

510(k) Number K992308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1999
Decision Date September 13, 1999
Days to Decision 66 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 160d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQE Needle, Assisted Reproduction

All 23
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K992308.
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
K000205 · Rocket Medical Plc · Apr 2000
OOCYTE ASPIRATION NEEDLE
K991271 · Casmed UK · Mar 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · Cook Urological, Inc. · Mar 2000
DOUBLE LUMEN NEEDLE
K991020 · Intl., Inc. · Sep 1999
SINGLE LUMEN NEEDLE
K991262 · Intl., Inc. · Sep 1999
SINGLE LUMEN SIDEPORT NEEDLE
K991264 · Intl., Inc. · Sep 1999